(42 days)
Not Found
No
The summary mentions an "image processing system" but does not explicitly mention AI, ML, or related terms, nor does it describe any AI/ML-specific features or performance metrics.
No
The device is used for imaging and visualization of anatomical structures, not for treating or rehabilitating a condition.
No
The device is described as an imaging system (fluoroscopic/angiographic and radiographic system) used to visualize anatomical structures. While imaging is often used in diagnosis, the device itself performs the visualization, not the diagnosis. The act of diagnosis is typically performed by a clinician interpreting the images.
No
The device description clearly states it is a "multidirectional fluoroscopic/angiographic and radiographic system, incorporating a C-arm supporting base and an integrated patient tilting table into one system," indicating it is a hardware system, not software-only.
Based on the provided information, the VERSIFLEX is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the VERSIFLEX is for visualizing anatomical structures and blood vessels using x-radiation and contrast medium. This is an in vivo diagnostic process (examining within a living organism), not an in vitro process (examining outside the body, typically with biological samples).
- Device Description: The description details a fluoroscopic/angiographic and radiographic system, which are imaging modalities used on patients.
- Input Imaging Modality: The input is x-radiation, which is used for imaging the body directly.
- Anatomical Site: The device is used to visualize anatomical structures, heart, and blood vessels within a patient.
IVD devices are typically used to examine biological samples (like blood, urine, tissue) outside of the body to diagnose diseases or conditions. The VERSIFLEX is an imaging system used directly on a patient.
N/A
Intended Use / Indications for Use
The VERSIFLEX is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
Product codes (comma separated list FDA assigned to the subject device)
90 IZI, 90 JAA
Device Description
The Hitachi VERSIFLEX is a new product. The VERSIFLEX is a multidirectional fluoroscopic/angiographic and radiographic system, incorporating a C-arm supporting base and an integrated patient tilting table into one system. With this system it is possible to carry out fluoroscopic/angiographic or radiographic examinations from various angles, and in combination with an X-ray generating unit and an image processing system, it can be used for multi-purpose examinations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-radiation
Anatomical Site
anatomical structures, heart, blood vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The VERSIFLEX is being tested to UL-2601 and will not be marketed until the testing reaches a successful conclusion.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
510(k) Summary
Hitachi Versiflex
Common/Classification Name: System, 21 CFR 892.1650, 892.1650
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, OH 44087-2371
330-425-1313, 330-425-1410 (FAX) Contact: John T. Newland, Prepared: March 19, 1999
LEGALLY MARKETED PREDICATE DEVICES A.
The Hitachi VERSIFLEX is substantially equivalent to the presently marketed Hitachi SX-VA30 Fluoroscopy/Angiography System (as cleared in K964990). The VERSIFLEX is manufactured by Hitachi Medical Corporation, Hitachi Hagoromo Building, 1-2-10 Uchi-Kanda, Chiyoda-Ku, Tokyo, 101, Japan. This 510(k) is submitted because the VERSIFLEX is a new device.
DEVICE DESCRIPTION B.
The Hitachi VERSIFLEX is a new product. The VERSIFLEX is a multidirectional fluoroscopic/angiographic and radiographic system, incorporating a C-arm supporting base and an integrated patient tilting table into one system. With this system it is possible to carry out fluoroscopic/angiographic or radiographic examinations from various angles, and in combination with an X-ray generating unit and an image processing system, it can be used for multi-purpose examinations.
C. INTENDED USE
The VERSIFLEX is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The Hitachi VERSIFLEX has an indications for use statement that is
1
almost identical to that of the legally marketed predicate device. That is, it has the same intended use. The Hitachi VERSIFLEX has the "same technological characteristics" as the predicate devices, and these characteristics are sufficiently precise to assure substantial equivalence.
TECHNOLOGICAL CHARACTERISTICS E.
The technological characteristics of the Hitachi VERSIFLEX are the same as for the SX-VA30 C-Arm Floroscopic/Angiographic System.
F. TESTING
The VERSIFLEX is being tested to UL-2601 and will not be marketed until the testing reaches a successful conclusion.
CONCLUSIONS G.
Hitachi Medical Systems America has demonstrated that the Hitachi VERSIFLEX is substantially equivalent to the Hitachi SX-VA30 Fluoroscopy/Angiography System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle, there is a stylized image of three human profiles facing to the right, represented by curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 1999
Hitachi Medical Corporation C/O Whit Athey, Ph.D. Senior Consultant C.L. Macintosh & Associates, Inc. Medical & Regulatory Affairs Services 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
Re:
K991231 Hitachi Versiflex Dated: April 12, 1999 Received: April 12, 1999 Regulatory Class: II 21 CFR 892.1600/Procode: 90 IZI 21 CFR 892.1650/Procode: 90 JAA
Dear Mr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Indications For Use:
The SF-VA200 is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergman
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K991231
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use